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Vitamin E Level in Buccal Cells of Arsenicosis Patients

Primary Purpose

Chronic Arsenic Poisoning

Status
Completed
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Vitamin E
Sponsored by
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Arsenic Poisoning focused on measuring Arsenic, Arsenicosis, Buccal cells, Serum, Vitamin E, Cholesterol

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

For arsenicosis

  • who drank arsenic contaminated water (>50 µg/L) for more than 6 months
  • having physical signs of moderate degree of melanosis and keratosis

For arsenic exposed control

  • relative or family member of the patient
  • showing no physical signs of melanosis and keratosis
  • share same tube well water for drinking purpose for more than 6 months

For healthy volunteers

  • who drank arsenic safe water (<50 µg/L)
  • live in the same Upazilla
  • have no cutaneous manifestation
  • who voluntarily agree to participate

Exclusion Criteria:

  • tuberculosis, eczema psoriasis, contact dermatitis
  • patients getting treatment of arsenicosis
  • subject who voluntarily do not agree to participate

Sites / Locations

  • Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Arsenicosis patients

Arsenic exposed controls

Heathy volunteers

Arm Description

Vitamin E (200 IU, caplet) daily orally for 20 weeks

vitamin E (200 IU, caplet) daily orally for 20 weeks

Vitamin E (200 IU, caplet) daily orally for 20 weeks

Outcomes

Primary Outcome Measures

Change in the amount of vitamin E in buccal cells
Changes in the amount of vitamin E in buccal cells of arsenicosis patients, arsenic exposed controls and healthy volunteers will be estimated both before and after supplementation with vitamin E for 20 weeks.

Secondary Outcome Measures

Changes in the amount of cholesterol in buccal cells
Changes in the amount of cholesterol in buccal cells of arsenicosis patients, arsenic exposed controls and healthy volunteers will be estimated both before and after supplementation with vitamin E for 20 weeks.
Changes in the concentration of vitamin E in serum
Changes in the concentration of vitamin E in serum of arsenicosis patients, arsenic exposed controls and healthy volunteers will be estimated both before and after supplementation with vitamin E for 20 weeks.
Changes in the concentration of cholesterol in serum
Changes in the concentration of cholesterol in serum of arsenicosis patients, arsenic exposed controls and healthy volunteers will be estimated both before and after supplementation with vitamin E for 20 weeks.

Full Information

First Posted
December 1, 2012
Last Updated
December 4, 2012
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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1. Study Identification

Unique Protocol Identification Number
NCT01743066
Brief Title
Vitamin E Level in Buccal Cells of Arsenicosis Patients
Official Title
Vitamin E Level in Buccal Cells of Arsenicosis Patients Following Vitamin E Supplementation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To understand the pathogenesis of chronic arsenic toxicity, the investigators need to know the levels of vitamin E in patients chronically exposed to high concentration of arsenic and if changes are found, what happens when supplemented with vitamin E. The buccal cells and serum of patients will be collected for the estimation of vitamin E both before and after supplementation with vitamin E. Similar samples will be collected from similar number of arsenic exposed controls and healthy volunteers for comparison.
Detailed Description
Chronic consumption of arsenic through water (drinking and cooking) and food leads to accumulation of arsenic within the cell. We usually give emphasis on the skin manifestations (melanosis and keratosis) of arsenicosis that is diagnosed first. Other manifestations remain un-diagnosed or diagnosed later. The severe form is the development of cancer in different organs mainly skin, lungs and urinary bladder. To understand the pathophysiology of the development of clinical manifestations appearing in the skin first, we need to understand interior of cells other than skin. One of the dietary supplements, vitamin E is found to be effective in improving the clinical signs/symptoms of melanosis and keratosis. Buccal cells are also exposed to arsenic and easy to collect. To understand the pathogenesis, we need to know the levels of vitamin E in patients of arsenicosis and if changes, what happens when supplemented with vitamin E. The buccal cells and serum of 20 patients will be collected for the estimation of vitamin E both before and after supplementation with vitamin E (200 IU, caplet) daily orally for 20 weeks. Similar samples will be collected from 20 arsenic exposed controls and 20 healthy volunteers for comparison.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Arsenic Poisoning
Keywords
Arsenic, Arsenicosis, Buccal cells, Serum, Vitamin E, Cholesterol

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arsenicosis patients
Arm Type
Experimental
Arm Description
Vitamin E (200 IU, caplet) daily orally for 20 weeks
Arm Title
Arsenic exposed controls
Arm Type
Active Comparator
Arm Description
vitamin E (200 IU, caplet) daily orally for 20 weeks
Arm Title
Heathy volunteers
Arm Type
Active Comparator
Arm Description
Vitamin E (200 IU, caplet) daily orally for 20 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin E
Intervention Description
vitamin E (200 IU, caplet) daily orally for 20 weeks
Primary Outcome Measure Information:
Title
Change in the amount of vitamin E in buccal cells
Description
Changes in the amount of vitamin E in buccal cells of arsenicosis patients, arsenic exposed controls and healthy volunteers will be estimated both before and after supplementation with vitamin E for 20 weeks.
Time Frame
0 week (baseline), 20 weeks (end)
Secondary Outcome Measure Information:
Title
Changes in the amount of cholesterol in buccal cells
Description
Changes in the amount of cholesterol in buccal cells of arsenicosis patients, arsenic exposed controls and healthy volunteers will be estimated both before and after supplementation with vitamin E for 20 weeks.
Time Frame
0 week (baseline), 20 weeks (end)
Title
Changes in the concentration of vitamin E in serum
Description
Changes in the concentration of vitamin E in serum of arsenicosis patients, arsenic exposed controls and healthy volunteers will be estimated both before and after supplementation with vitamin E for 20 weeks.
Time Frame
0 week (baseline), 20 weeks (end)
Title
Changes in the concentration of cholesterol in serum
Description
Changes in the concentration of cholesterol in serum of arsenicosis patients, arsenic exposed controls and healthy volunteers will be estimated both before and after supplementation with vitamin E for 20 weeks.
Time Frame
0 week (baseline), 20 weeks (end)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: For arsenicosis who drank arsenic contaminated water (>50 µg/L) for more than 6 months having physical signs of moderate degree of melanosis and keratosis For arsenic exposed control relative or family member of the patient showing no physical signs of melanosis and keratosis share same tube well water for drinking purpose for more than 6 months For healthy volunteers who drank arsenic safe water (<50 µg/L) live in the same Upazilla have no cutaneous manifestation who voluntarily agree to participate Exclusion Criteria: tuberculosis, eczema psoriasis, contact dermatitis patients getting treatment of arsenicosis subject who voluntarily do not agree to participate
Facility Information:
Facility Name
Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University
City
Dhaka
Country
Bangladesh

12. IPD Sharing Statement

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Vitamin E Level in Buccal Cells of Arsenicosis Patients

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